Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202305829197067 Date of Approval: 02/05/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Aerobic Training Versus Resistance Training on Plasma Homocystiene in Diabetic Patients
Official scientific title Effect of Aerobic Training Versus Resistance Training on Plasma Homocystiene in Diabetic Patients
Brief summary describing the background and objectives of the trial Homocysteine (Hcy) may be implicated in the development of many diseases including DM and could aggravate insulin resistance (IR) and vascular endothelial dysfunction in patients with T2DM. The regulation of enzymes involved in Hcy metabolism in DM is complex and may be affected by cellular stress, diet, genomic background and the epigenetic milieu Type 2 diabetes is associated with a cluster of interrelated plasma lipid and lipoprotein abnormalities, including reduced HDL cholesterol, a predominance of small dense LDL particles, and elevated triglycerides. It is well established that physical exercise reduces the risk of cardiovascular disease . Studies have furthermore demonstrated exercise alters Hcy levels in the blood in rodents and humans. so the Purpose of the study is to compare between the efficacy of aerobic exercises versus resistance exercises on homocysteine, cholesterol and insulin levels in diabetic patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 02/03/2022
Actual trial start date 26/06/2022
Anticipated date of last follow up 26/02/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 60
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
P.T.REC/012/003654
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group aerobic exercises 3 times/ week for 12 weeks 30-45 mins 5-10 mins warming up 20-25 mins walking on treadmill at moderate intensity 5-10 mins cooling down walking on treadmill Intensity: started by 60-75% of target heart rate according to each patient response. Duration: Each session consisted of five minutes warming up firstly then 30-340 minutes time of session ended by five minutes cool down exercises 20
Experimental Group resistance exercises group 3 times/week for 3 months 30-45 mins 5-10 warming up 20-25 exercises phase 5-10 cooling down well-established resistance training exercises 30-45 mins. The subject will warm up and cool down for at least five to seven minutes each, (before and after exercise) with initial load of 60% of 1 repetition maximum. This program consists of 3 sets of 8 to 12 repetitions, then increasing load when subject was able to complete 12 repetitions. A rest period of 1.5 min was established between each set. Mode: 4 upper body exercises (bench press, seated row, shoulder press, and pull down), 3 leg exercises (leg press, extension, and flexion), abdominal crunches and back extensions. with the individualized workloads at 60% of 1RM. 20
Control Group medications only 12 weeks medications for type 2 diabetes (oral hypoglycemic ) only 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Their ages will range from 40 -55 years. 2-Their body mass indexes will range between (25 to 35 Kg / m²). 3-All patients are diagnosed with type 2 diabetes mellites. - Diagnostic criteria for type 2 diabetes were: 1) a fasting plasma glucose concentration of 7.0 mmol·L-1 or higher or 2) a plasma glucose concentration of 11.1 mmol·L-1 or higher two hours after an oral glucose challenge - All subjects took oral hypoglycemic drugs but none of them were being treated with insulin when enrolled. 4- All patients are medically and psychologically stable 1- Patients with uncontrolled blood glucose level 2- Patients with unstable cardiovascular conditions (those with a known history of uncontrolled hypertension, ischemic attacks, stroke, congestive heart failure, currently on anticoagulation therapy) were excluded from this study. 3- Patients with severe pulmonary disease (with restrictive lung disease or with obstructive lung disease). 4- Patients with musculoskeletal disorders (Diagnosed with severe osteoporosis or severe osteoarthritis). 5- Patients with BMI > 35 will be excluded from the study. Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 55 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/02/2022 faculty of physical therapy research ethics
Ethics Committee Address
Street address City Postal code Country
7- ahmed el-zayat Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome homocystiene level pre and post treatment
Primary Outcome insulin level pre and post treatment
Primary Outcome cholestrol level pre and post treatment
Secondary Outcome functional capacity by six-minute walk test pre and post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy Egyptian Chinese university 14 Abou ghazalh Manshyea El-tahrir , Ain shams cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hanan abdallah elsayed hassan madinty group 69 block 23 flat 52 cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy cairo university 7 Ahmed Elazyat street giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hanan Hassan hananabdalla@ecu.edu.eg 01060612903 madinty group 69 block 23 flat 52
City Postal code Country Position/Affiliation
cairo Egypt teaching assistant at faculty of physical therapy at Egyptian Chinese University
Role Name Email Phone Street address
Public Enquiries Akram Sayed akram.sayed70@yahoo.com 01003995129 7 Ahmed Elzayat
City Postal code Country Position/Affiliation
giza Egypt Assistant Professor of Physical Therapy at Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Mona Morsy mona.morsy83@yahoo.com 01228700357 7 Ahmed Elzayat
City Postal code Country Position/Affiliation
giza Egypt Lecturer of Physical Therapy at Faculty of Physical Therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all of the individual participant data collected during the trial , after de-identification Clinical Study Report,Study Protocol immediately following publication, no end date anyone who wishes to access the data for any purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
will be added later No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information